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510(k) Data Aggregation

    K Number
    K202800
    Device Name
    Pacific Plus PTA Catheter
    Manufacturer
    Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc)
    Date Cleared
    2020-11-18

    (56 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.
    Device Description
    The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel. The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.
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